Allogene Reports the US FDA’s Clinical Hold on ALPHA2 Study of ALLO-501A to Treat Large B Cell Lymphoma

 Allogene Reports the US FDA’s Clinical Hold on ALPHA2 Study of ALLO-501A to Treat Large B Cell Lymphoma

Allogene Reports the US FDA’s Clinical Hold on ALPHA2 Study of ALLO-501A to Treat Large B Cell Lymphoma

Shots:

  • The US FDA has placed a clinical hold on the ALPHA2 study that evaluates ALLO-501A CAR T in 100+ patients with large B-cell lymphoma
  • The discontinuation is due to the observation of chromosomal abnormality in ALLO-501A CAR T cells which was detected in a bone marrow biopsy to test the patient with low blood counts. Additionally, the investigation is underway to identify the abnormality including clinical relevance, clonal expansion, or gene editing
  • The company expects to provide additional updates in the coming wks., following the US FDA’s discussion. The FDA continues to review the P-I data to further supports the P-II ALLO-501A trial

Click here to read full press release/ article | Ref: Allogene | Image: Allogene

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